Opinion of the Scientific Committee on Cosmetic and non-food products intended for Consumers concerning 11-Alpha-Hydroxypregn-4-Ene 3,20-Dione adopted by the plenary session of the SCCNFP of 21 January 1998

- Lack of data on
sub-chronic and chronic
toxicity; no available NOAEL.

Percutaneous absorption:

- Permeation rate of the
same order of magnitude as
progesterone.

Assessment of
genotoxicity/carcinogenicity:

- Lack of data on
genotoxicity

- Inadequate data on
carcinogenicity.

Assessment on
reproductive toxicity:

- No data.

Assessment on endocrine
activity:

- Mineralocorticoïd like
effects in vitro and in vivo

- Some antiandrogenic or
antioestrogenic effects.

Classification: 2a

SCCNFP Opinion

The available
toxicological data are
insufficient as to support the
safe use of
11alpha-Hydroxypregn-4-ene,
3,20 dione (11alpha- OHP) in
cosmetic products. However it
is known that 11alpha- OHP is
not irritant to human skin, and
that its percutaneous
absorption is of the same order
of magnitude as progesterone.

It appears probably that
the purity grade - the
progesterone content - of
11alpha- OHP participates in
some of the endocrine
activities observed. Very
recent studies have shown that
11alpha- OHP is a very potent
inhibitor of the glucocorticoïd
inactivating enzymes 11
beta-Hydroxysteroïd
dehydrogenases in vitro and
conferred potent
mineralocorticoïd activity at
low doses in adrenalectomized
rats. These effects were shown
to be mediated via
mineralocorticoïd receptors and
could be correlated with potent
hypertensive effects.

The SCC is of the
opinion that 11alpha- OHP and
its esters must not be used in
cosmetic products.

Statement on the
toxicological evaluation

The SCCNFP is the
scientific advisory body to the
European Commission in matters
of consumer protection with
respect to cosmetics and
non-food products intended for
consumers.

The Commission's general
policy regarding research on
animals supports the
development of alternative
methods to replace or to reduce
animal testing when possible.
In this context, the SCCNFP has
a specific working group on
alternatives to animal testing
which, in co-operation with
other Commission services such
as ECVAM (European Centre for
Validation of Alternative
Methods), evaluates these
methods.

SCCNFP opinions include
evaluations of experiments
using laboratory animals; such
tests are conducted in
accordance with all legal
provisions and preferably under
chemical law regulations. Only
in cases where no alternative
method is available will such
tests be evaluated and the
resulting data accepted, in
order to meet the fundamental
requirements of the protection
of consumer health.